Equipment Design Process Engineer (Medical Devices)

Location: Austin, TX, United States; onsite work in an office, engineering lab, and Class 8 cleanroom. Travel up to 50%, primarily to Costa Rica, is required during critical project phases.

Company

hirify.global develops and manufactures medical devices and components, including Nitinol components, stents, catheters, delivery systems, biomedical textiles, access kits, and guidewires.

What you will do

• Design, prototype, build, debug, validate, and deploy semi-automated and automated fixtures and stations for catheter manufacturing and assembly.
• Convert manual catheter assembly operations into repeatable, error-proofed processes with appropriate operator interaction.
• Integrate PLC controls, pneumatics, servos, solenoids, sensors, machine vision, and automated dispensing equipment.
• Develop processes and equipment for braiding, lamination, bonding, dispensing, tipping, soldering, and inspection.
• Lead equipment acceptance activities, DOE studies, process characterization, and IQ/OQ/PQ validation.
• Support process and equipment transfers to Costa Rica, mentor junior engineers, and standardize automation architectures across sites.

Requirements

• Bachelor’s degree in mechanical, manufacturing, mechatronics, electrical engineering, or a related field.
• 3–5+ years of experience in manufacturing equipment design, preferably involving small-scale assemblies.
• Hands-on experience designing, building, programming, and debugging semi-automated fixtures or stations using PLC-based, pneumatic, or other motion controls.
• Proficiency in SolidWorks for models, assemblies, and drawings.
• Experience with process characterization, validation, and control, including DOE, IQ/OQ/PQ, and SPC.
• Employment visa sponsorship is not available, and candidates on time-limited visa status will not be considered.

Nice to have

• Minitab experience.
• Green or Black Belt certification.
• Experience in medical device or other highly regulated manufacturing environments.
• Experience with robotics, motion systems, machine vision, sensors, automated dispensing equipment, or catheter assembly materials.

Culture & Benefits

• Collaborative work with customers and cross-functional engineering teams.
• Technical leadership opportunities without direct managerial responsibility.
• Hands-on work across office, engineering lab, and cleanroom environments.
• Occasional cleanroom gowning, extended standing at development benches, and lifting up to 50 lbs. are required.